Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients.
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Confirmed Thromboembolic Events
Study Overview
Brief Summary
The purpose of this study is to compare the efficacy and safety of dalteparin vs unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized acutely ill medical patients.
Detailed Description
The study was prematurely discontinued due to delay in overall study start-up and inability to meet pre-defined protocol recruitment milestones on June 30th, 2008. There were no safety concerns regarding the study in the decision to terminate the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged greater than or equal to 18 years
- •Acute medical condition with a projected hospitalization of greater than or equal to 4 days and had less than or equal to 3 days of prior immobilization for more than two thirds of the day
- •Acute congestive heart failure Class III-IV per NHYA/ Acute respiratory failure not requiring mechanical ventilation or Both
- •Acute infection without septic shock/ Acute episode of inflammatory bowel disease/ Acute rheumatologic disorders/ Acute lumbar pain or sciatica or vertebral compression with at least one risk factor for VTE
Exclusion Criteria
- •Contraindications to use of anticoagulants
- •Active bleeding or abnormal coagulation tests
- •Recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or intracranial aneurysm or ischemic stroke within the last month.
- •Major surgical or invasive procedure within the last month resulting in ongoing convalescence
- •Lumbar or spinal puncture within last 48 hours
- •S creatinine levels more than 2
- •On inotropic agents
Arms & Interventions
B
Intervention: Unfractionated heparin (Drug)
A
Intervention: Dalteparin (Fragmin) (Drug)
Outcomes
Primary Outcomes
Confirmed Thromboembolic Events
Time Frame: Day 21
Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.
Composite of Objectively Verified Thromboembolic Events
Time Frame: Day 21
Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis \[DVT\], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism \[PE\] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.
Secondary Outcomes
- All Cause Mortality(Day 14, Day 21 (End of Study))
- Stroke - Ischemic or Hemorrhagic(Day 21)
- Bleeding - Major or Minor(Day 21)
- Allergic Reactions (Drug-related)(Day 21)
- Thrombocytopenia(Day 21)